FDA Approves New Cholesterol Drug

08/13/2009 - News

FDA Approves New Cholesterol Drug

By: June Chen, MD

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Last week, the U.S. Food and Drug Administration (FDA) approved pitavastatin, a new cholesterol-lowering drug. Pitavastatin is indicated for the primary treatment of high cholesterol and combined dyslipidemia.

Pitavastatin, which will be marketed as Livalo®, is the newest statin therapy to be introduced for cholesterol-lowering. The FDA’s approval of pitavastatin is based upon evidence from five Phase III trials demonstrating its efficacy in lowering low density lipoprotein (LDL) cholesterol in elderly patients, diabetics, and patients at higher cardiovascular risk.
 
Livalo is expected to launch in the U.S. in early 2010, and this cholesterol-lowering drug will be available in three dosages.
 

Source:

U.S. Food and Drug Administration website, accessed August 5, 2009.

Created on: 08/13/2009
Reviewed on: 08/13/2009

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